COMPACTROL

(Calcium Sulfate Dihydrate, NF)

DESCRIPTION:
1

Compactrol is the dihydrate form of Calcium Sulfate (CaSO4), a white to slightly off-white powder
with a median particle size of 120 m.

APPLICATIONS AND USE:

Compactrol is a specially-processed grade of calcium sulfate with a particle size ideally suited for use
in pharmaceutical tablets which are made by direct compression. It is an efficient and relatively
inexpensive tablet and capsule filler.

Compactrol is a non-hygroscopic and free-flowing product that offers excellent long-term stability.
The particle size distribution is within the range of a great majority of active ingredients, thereby
ensuring uniform blending and close uniformity. Because of its high bulk density and free-flowing
characteristics, it imparts a high degree of fluidity which is essential for high-speed compaction and
filling.

MONOGRAPH SPECIFICATIONS:

Compactrol complies with the monograph for Calcium Sulfate Dihydrate in the NF.
1.
2.

Appearance
Identification

3.
4.
5.
6.

Loss on drying
Iron
Heavy metals
Assay

A white to slightly off-white powder.

Responds to the tests for Calcium <191> and for
Sulfate <191>.
19.0 - 23.0 %
Not more than 0.01%
Not more than 0.001%
98.0 101.0 %

ADDITIONAL SPECIFICATIONS:
1.
2.

Lead
Organic Volatile Impurities

Not more than 10 ppm

Meets the requirements

Compactrol is a registered trademark of JRS Pharma LP (Rettenmaier)

Issued March 2003

TDS.QA0.10002.00000.02
Page 1 of 2
US Office: Phone 845-878-3414 1-800-431-2457 Fax 845-878-3484
UK Office: Phone +44 1737 222323 Fax +44 1737 222545

COMPACTROL
(Calcium Sulfate Dihydrate, NF)

ADDITIONAL SPECIFICATIONS (continued):

2

3.

Particle size (by Ro-Tap )

4.
5.

Bulk density
Tapped density

Not less than 85.0% is retained on a #140 mesh

sieve (100 m)
Not less than 98.0% passes through a #40 mesh
sieve (425 m)
Not more than 1.10 g/mL
0.90 - 1.35 g/mL

Identification and heavy metals: Results shown represent expected results based on historical data. JRS
Pharma warrants that this material, if tested, will conform to the specification listed for each test.
Assurance that this product meets the Organic Volatile Impurities (OVI) specifications as listed in USP
<467> is based on the knowledge that there is no potential for the specific toxic solvents to be present in
the material. The product is not exposed to any OVIs during our manufacturing, handling, shipping, and
storage. JRS Pharma warrants that this material, if tested, will comply with the established standards.

PACKAGING:

Compactrol is available in 25-kg four-ply bags, including a polyethylene layer.

STORAGE RECOMMENDATIONS:

Compactrol should be stored in original, unopened, well-closed containers under conditions that do

not typically exceed 30C and 70% RH. When stored as recommended, Compactrol has a
recommended re-evaluation period of three (3) years from the date of manufacture. An additional year
can be added if the LOD and assay test within test specifications.

ADDITIONAL TECHNICAL INFORMATION:

Chemical Abstract Service (CAS) Registry number: 10101-41-4
Brussels Nomenclature number: 2520 20 90 0 00

WARRANTY:
The information contained in this document is believed to be accurate at the time of issuance and is
offered in good faith, with no assumption of liability on the part of JRS Pharma, as a guide to the use
and testing of the material, but in no way does this information constitute a performance warranty. JRS
Pharma excipients are sold with the understanding that purchasers will determine the suitability of the
excipients for their particular applications or purposes.

2 Ro-Tap is a registered trademark of W.S. Tyler, Inc.

Issued March 2003

TDS.QA0.10002.00000.02
Page 2 of 2
US Office: Phone 845-878-3414 1-800-431-2457 Fax 845-878-3484
UK Office: Phone +44 1737 222323 Fax +44 1737 222545